MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number M0062201090

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an occluder balloon catheter was used during a kidney stone removal procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon have deflation problems.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem), block d7 (sud reprocessed and reused), h6 (device codes) and block h8 (usage of device).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an occluder balloon catheter was used during a kidney stone removal procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon have deflation problems.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.Additional information received on october 13, 2021 note: this report pertains to one of two occluder balloon catheters used in the same patient and procedure.It was reported that both balloons did not have deflation problems but instead would just not inflate.

Manufacturer Narrative

Block h6: device code a0402 captures the reportable investigation findings of balloon burst.Block h10: investigation result a visual examination of the returned complaint device found the balloon was ruptured, thereby confirming the reported event of balloon would not inflate.The balloon lumen and the distal lumen were in a good shape.Additionally, the stopcock was returned with the device.Functional evaluation could not be performed due to the condition of the returned device.This problem is likely due to factors encountered during the procedure, such as the inflation of the balloon or the insertion of the balloon through the scope could have affected the device performance and its intended purpose, leading to the found problem of balloon burst.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that an occluder balloon catheter was used during a kidney stone removal procedure performed on (b)(6), 2021.During the procedure, it was noticed that the balloon have deflation problems.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.**additional information received on (b)(6), 2021** note: this report pertains to one of two occluder balloon catheters used in the same patient and procedure.It was reported that both balloons did not have deflation problems but instead would just not inflate.

• Brand Name: OCCLUDER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12672007
• MDR Text Key: 277683947
• Report Number: 3005099803-2021-05290
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0027062049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1